Brand Name

    US Brand Name

    Biorphen

    Vazculep


    Description

    Phenylephrine injection is used to treat hypotension (low blood pressure) that may occur during surgery.

    This medicine is to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of phenylephrine injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of phenylephrine injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving phenylephrine injection.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Dihydroergotamine
    • Linezolid
    • Rasagiline
    • Selegiline

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Amphetamine
    • Dextroamphetamine
    • Ergonovine
    • Iobenguane I 123
    • Iobenguane I 131
    • Lisdexamfetamine
    • Methylergonovine
    • Midodrine
    • Zavegepant

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergy to sulfites or
    • Asthma—This medicine contains sodium metabisulfite, which can make these conditions worse.
    • Angina, or history of or
    • Bradycardia (slow heartbeat) or
    • Blood vessel problems (eg, arteriosclerosis), severe or
    • Heart failure or
    • Peripheral vascular disease or
    • Pulmonary arterial hypertension or
    • Spinal cord injury—Use with caution. May make these conditions worse.
    • Kidney disease, severe or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.


    Precautions

    Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

    This medicine may cause a permanent depression (necrosis) under the skin at the injection site. Tell your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Blurred vision
    • chest pain or discomfort
    • difficult or labored breathing
    • dizziness
    • fainting
    • fast, slow, or irregular heartbeat
    • headache
    • nausea or vomiting
    • nervousness
    • pain in the shoulders, arms, jaw, or neck
    • pounding in the ears
    • sweating
    • tightness in the chest
    • unusual tiredness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Feeling of fullness in the head
    • pounding or rapid pulse
    • tingling in the arms or legs
    • vomiting

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Heartburn
    • itching skin
    • nausea
    • pain in the neck
    • pain or discomfort in chest, upper stomach, or throat

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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